FDA 510(k)

口腔装置 OA，口腔装置 S

K号: K181396 · 2018-11-16

申请人Passion For Life Healthcare (Uk) Limited

决定日期2018-11-16

产品代码LRK

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决定实质等同

器械摘要

Oral Device OA, Oral Device S is the device name listed in this FDA 510(k) record. The listed applicant is Passion For Life Healthcare (Uk) Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181396. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oral Device OA, Oral Device S?

Oral Device OA, Oral Device S is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Passion For Life Healthcare (Uk) Limited. The 510(k) number is K181396.

When did Oral Device OA, Oral Device S receive FDA 510(k) clearance?

Oral Device OA, Oral Device S received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181396.

Who is the listed applicant for Oral Device OA, Oral Device S?

The FDA 510(k) record lists Passion For Life Healthcare (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral Device OA, Oral Device S?

The FDA product code for Oral Device OA, Oral Device S is LRK.

官方来源

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口腔装置 OA，口腔装置 S

器械摘要

常见问题

相关临床试验

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官方来源